An Anti-viral Combination Study With Japanese Hepatitis C Infection (HCV) Subject

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Hepatitis C Infection

Treatments: Drug: BMS-790052; Drug: BMS-650032

Study type: Interventional

Funder types: Industry

Identifiers

NCT01051414

AI447-017

Details and patient eligibility

About

To assess the efficacy and safety profile of co-administration of BMS-790052 and BMS-650032 for 24 weeks treatment.

Enrollment: 43 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects chronically infected with HCV Genotype 1
• HCV RNA viral load of ≥ 10*5* IU/mL (100,000 IU/mL) at screening

Exclusion criteria

• Subjects with evidence of liver cirrhosis
• Evidence of HCC
• Co-infection with hepatitis B virus, HIV

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

BMS-790052 + BMS-650032

Experimental group

Treatment:

Drug: BMS-790052

Drug: BMS-650032